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Biotech / Medical : VD's Model Portfolio & Discussion Thread -- Ignore unavailable to you. Want to Upgrade?

To: Vector1 who wrote (5535)	9/1/1998 10:50:00 AM
From: Rocketman	Read Replies (2) \| Respond to of 9719

AVIRON TANKING BIG ON FDA NON-APPROVABLE LETTER Down $10+ -46% at the moment!!! Classic overreaction, now's the time to buy if you've got the bullets. This is standard minor FDA document BS that is easily doable by the company. This does not threaten the approval, except by maybe pushing out the timeline a bit. <<<<<<< Tuesday September 1, 12:44 am Eastern Time Company Press Release SOURCE: Aviron Aviron Receives Non-Filable Notification From FDA on FluMist; Company To Resubmit Application with Additional Information on Manufacturing and Process Validation MOUNTAIN VIEW, Calif., Aug. 31 /PRNewswire/ -- Aviron (Nasdaq: AVIR - news) announced today that it has received notification from the U.S. Food and Drug Administration that its regulatory submission for FluMist(TM), its live attenuated intranasal influenza vaccine, was not accepted for filing. Aviron has requested a meeting with FDA to clarify the specific information that will be required. The FDA stated that it requires additional information on the manufacturing processes and the facilities where the vaccine will be manufactured. No information was requested pertaining to the safety or efficacy data for FluMist(TM). The company submitted its original Product License Application/Establishment License Application (PLA/ELA) to the FDA on June 30, 1998. Bulk vaccine for the company's clinical trials is currently manufactured by Medeva Pharma Ltd. (formerly known as Evans Medical) at a facility near Liverpool, England. A related PLA/ELA covering bulk manufacturing submitted by Medeva Pharma was also the subject of a refusal to file notification. The bulk formulation is then transferred to Packaging Coordinators, Inc. (PCI), in Philadelphia for blending, filling, packaging and labeling and storage. ''We intend to work closely with the FDA in order to enable the earliest possible review of our submission,'' said J. Leighton Read, M.D., Aviron's chairman and chief executive officer. ''Most of the additional information the FDA has requested is on-track and was already planned for submission in October.'' The company noted that one important issue that may delay re-filing beyond October is a potential FDA requirement for another trial to bridge from the manufacturing process used for the Phase 3 pivotal trial to the process planned for commercial production. ''Aviron intends to discuss the need for such a trial with the FDA as soon as possible,'' Dr. Read added. ''However, if such a trial were conducted, it would take at least six months to conduct the trial and report results. Additional stability data could also be required. This potential delay might significantly reduce the chance that FluMist(TM) would be approved in time for the 1999-2000 flu season.'' ''Aviron is currently in late-stage discussions with several potential marketing partners and is reviewing these recent developments with them,'' Dr. Read added. ''When we have selected our partner, we will jointly decide whether to adjust our plans for the product launch timing from 1999-2000 to 2000-2001. This decision will be made in light of our pending discussions with FDA.'' Aviron is a biopharmaceutical company based in Mountain View, CA focused on prevention of disease. The company's goal is to develop products which offer cost-effective prevention of a wide range of infections that affect the general population. The majority of Aviron's products under development are live vaccines against viral infections. These include respiratory infections and their complications; influenza, parainfluenza (PIV-3), and respiratory syncytial virus (RSV); as well as cytomegalovirus (CMV) and genital herpes (HSV-2). Aviron is also developing, in collaboration with SmithKline Beecham Biologicals, a subunit vaccine against Epstein-Barr Virus (EBV) infection, a major cause of infectious mononucleosis. This press release contains forward-looking statements regarding the performance of Aviron. Actual results may differ materially from those suggested here. Additional information concerning factors that could cause such a difference is contained in Aviron's Annual Report on Form 10-K for year ending December 31, 1997. To receive an index and copies of recent press releases, call Aviron's News-On-Call toll-free fax service, 800-758-5804, extension 114000. Additional information about the company can be located at aviron.com. SOURCE: Aviron >>>>>>>